Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.

FDA Recall Z-2554-2026 · Posted 2026-06-24

Recalling FirmIPG Medical Corporation
Recall StatusOpen, Classified
Product CodeGEX
Date Initiated2026-05-05
Product Quantity198 units

Reason for Recall

Software anomaly that causes a false display of error code 5018.

Firm Action

An URGENT MEDICAL DEVICE RECALL notice dated 05/05/2026 was emailed to IPG Medical's consignee notifying them of this recall correction to address Error 5018 and Error 5007/5023 displayed on monitors with software version 2.2. The notification provides instructions to consignees to work around the error messages until a software upgrade is deployed at a later date. The notification instructs consignees that their staff may correct units onsite via software upgrade or units may be returned to IPG Medical for a factory correction when the update is available. A corrected IFU will be provided to all customers. Questions can be directed via phone to 774-633-5903 or [email protected].

Root Cause

Device Design

Distribution Pattern

US Nationwide distribution in the state of MA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K232568IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and AccessoriesIpg Medical Corporation · 2024-03-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑